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Recent And Upcoming FDA Advisory Committee Meetings

Executive Summary

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

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Aimmune’s Peanut Allergy Immunotherapy Brings Safety Concerns To US FDA Panel

Palforzia was associated with a higher rate of adverse events, systemic allergic reactions, eosinophilic esophagitis and epinephrine use in controlled clinical trials; Allergenic Products Advisory Committee will weigh approval for patients ages 4-17 years with confirmed peanut allergy diagnosis.

Medtech Multinationals Up Pace Of Localization Strategies In China

China-specific go-to-market strategies are helping global medtechs access the fast-growing medical device market in China, where localization has become the buzzword for foreign players, writes news and analysis portal Omdia.

Lack Of Interchangeability No Barrier For Amjevita, Says Amgen Executive

While Amgen’s Amjevita (adalimumab-atto) has yet to secure an interchangeability designation, company executives appear confident this will have little impact on their Humira biosimilar’s competitiveness overall.

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